Alphosyl 2 In 1 Shampoo
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alphosyl ‘2 in 1’ Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alcoholic extract of coal tar 5.00% w/w For excipients see 6.1
3 PHARMACEUTICAL FORM
Medicated Shampoo
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Coal tar shampoo is indicated for the treatment of scalp disorders including: -Psoriasis
-Seborrhoeic dermatitis -Eczema
-Pruritus and scaling associated with psoriasis, seborrhoeic dermatitis and eczema
-Itchy, oily scalp
-Dandruff.
4.2 Posology and method of administration
Adults and Children aged 12 years and older:
Alphosyl ‘2 in 1’ Shampoo is for topical application to the scalp.
The hair should be wetted and sufficient Alphosyl ‘2 in 1’ Shampoo applied to produce an abundant lather. The scalp and adjacent areas should be vigorously massaged with the fingertips. The hair should be then thoroughly rinsed and the procedure repeated. Taking both of these shampoo applications into consideration, the total leave on time for the shampoo should be 3-5 minutes.
Alphosyl ‘2 in 1’ Shampoo should be used once or twice weekly for the treatment of scalp disorders. The normal duration of use is 4 weeks, after which the condition should improve. Longer duration of therapy should be continued under the supervision of a physician.
Children:
The safety and efficacy of Alphosyl ‘2 in 1’ Shampoo in children under 12 years of age have not been established.
Coal tar preparations have been used in children for many years, but since there is very little documented clinical data in this patient population, Alphosyl ‘2 in 1’ Shampoo should be used with caution in children and only on the recommendation of a doctor or pharmacist.
Elderly:
No dosage adjustment is necessary.
Renal Impairment:
No dosage adjustment is necessary.
Hepatic impairment:
No dosage adjustment is necessary.
4.3 Contraindications
Known hypersensitivity to coal tar or to any of the excipients in the preparation.
The following conditions should not be treated with Alphosyl ‘2 in 1’ Shampoo: Infected open skin lesions Sore or acute pustular psoriasis
4.4 Special warnings and precautions for use
For cutaneous use only.
Coal tar preparations may cause irritancy; therefore contact with sensitive areas, such as broken or very inflamed skin, should be avoided.
If irritation develops, treatment should be discontinued.
Avoid contact with the eyes. If contact occurs rinse eyes thoroughly with water.
Alphosyl ‘2 in 1’ Shampoo can stain skin and clothes. Contact with clothes should be avoided. Skin stains will wear off after treatment is stopped.
In rare instances, temporary hair colour changes may occur.
As Alphosyl ‘2 in 1’ Shampoo may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure of the scalp to sunlight should be avoided or minimised.
Alphosyl ‘2 in 1’ Shampoo should be used with caution if the patient is also taking drugs known to be photosensitisers (e.g. thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulphonamides) because of the increased possibility of augmented photosensitivity.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
Fertility
There are no data on the effects of topical coal tar preparations on human fertility. Pregnancy
There are limited data from the use of coal tar preparations in pregnant women.
Coal tar has been shown to be foetotoxic and teratogenic to the offspring of laboratory animals when administered topically, orally or by inhalation at high and maternally toxic doses (see Non-clinical Information).
Use of coal tar preparations during pregnancy should only be considered if the expected benefit to the mother outweighs the potential risk to the foetus.
The use of coal tar products should be avoided in the first trimester of pregnancy.
Lactation
The safe use of topical coal tar preparations during lactation has not been established.
It is not known whether the topical application of coal tar preparations could result in sufficient systemic absorption to produce detectable amounts in breast milk.
Use of coal tar preparations during lactation should only be considered if the expected benefit to the mother outweighs the potential risk to the infant.
If used during lactation, patients should be advised to ensure that any residual product is fully washed off the breast prior to breast-feeding in order to avoid accidental ingestion by the infant.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Adverse drug reactions (ADRs) are listed below by the MedDRA system organ class and by frequency. Frequencies are defines as: very common (>1/10), common (>1/100 and <1/10) , uncommon (>1/1,0000 and <1/100), rare (>1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.
Post-marketing data
Immune system disorders
Rare: Hypersensitivity (including pruritus, angioedema, dyspnoea)
Eye disorders
Rare: Eye irritation
Skin and subcutaneous tissue disorders
Rare: Alopecia, dermatitis, hair colour changes, abnormal hair texture, photosensitivity reaction, skin irritation (including dry skin, erythema and skin burning sensation).
General disorders and administration site conditions
Rare: Application site hypersensitivity, application site pain, application site rash, localised oedema.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Symptoms and signs:
Topical coal tar overdose may increase the rate of skin irritation and photosensitivity. (see Adverse Reactions).
Treatment:
Management should be as clinically indicated or as recommended by the national poisons centre, where available.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code:
D05AA Tars
Mechanism of action
Coal tars suppress DNA synthesis in hyperplastic skin inhibiting mitotic activity, protein synthesis and cell reproduction.
Coal tar
Coal tar decreases epidermal proliferation and dermal infiltration and thus promotes a return to normal keratinisation. Coal tar has anti-inflammatory, antibacterial, antipruritic, keratolytic, keratoplastic and vasoconstrictive effects.
5.2 Pharmacokinetic properties
In a study using a variety of coal tar preparations total urinary poly aromatic hydrocarbons were significantly elevated in patients treated dermally for different forms of dermatoses. The treatment period was for an average of 7 days using 1.5% - 40% coal tar preparations over a body surface area that ranged from 9 to 90%. Therefore some of the hydrocarbons present in coal tar may be absorbed through the skin. The highest levels absorbed depend largely on the body surface area treated and on the duration of exposure.
Many of the hydrocarbons will be subject to extensive metabolic transformation by both oxidation and conjugation. Drug-metabolizing enzymes (both in the skin and systemically) may be induced by coal tar application.
5.3 Preclinical safety data
Carcinogenesis and Mutagenesis
No long term studies have been conducted with the product formulations. Coal tar contains certain chemicals that are mutagenic to microorganisms and mammalian cells in vitro. Topical and oral administration of high doses of coal tar to laboratory animals induces DNA adduct formation.
High dose administration of coal tar to laboratory animals is carcinogenic However, epidemiological evidence that includes prospective and retrospective studies in thousands of patients receiving coal tar therapy followed for more than 40 years do not suggest a potential increased risk of skin or systemic cancer.
Reproductive Toxicology
Coal tar is foetotoxic and teratogenic at maternally toxic doses following dermal application, oral administration, or inhalation.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium lauryl sulphate solution Ammonium lauryl sulphate solution Lauramide DEA Herbal Fragrance 41.423 Hydroxy Propyl Methyl Cellulose Citric acid anhydrous
Guar Hydroxy Propyl Trimonium Chloride Methyl Parahydroxybenzoate Propyl Parahydroxybenzoate Patent Blue V dye Purified Water
6.2 Incompatibilities
None known
6.3 Shelf life
24 months
6.4 Special precautions for storage
None
6.5 Nature and contents of container
Alphosyl ‘2 in 1’ shampoo is packaged in white opaque polypropylene bottles with wadded cap and pack sizes; 20, 100, 125, 250, 500 and 1000 ml
or
White opaque polypropylene bottles with a white polypropylene flip top cap and pack sizes 125 and 250ml.
It is also packaged in white opaque polypropylene tubes with screw cap and pack sizes 20, 100, 125, 250, 500 and 1000 ml.
It is also packaged in 10 ml PETP/PE/Foil Surlyn sachets.
6.6 Special precautions for disposal
None stated
7 MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd.
1st Floor
32 Vauxhall Bridge Road LONDON, SW1V 2SA United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 02855/0063
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/06/2008
10 DATE OF REVISION OF THE TEXT
06/07/2015